NOW AVAILABLE
AKYNZEO
®
is a registered trademark of Helsinn Healthcare SA, Switzerland, used under license.
Distributed and marketed by Eisai Inc., under license of Helsinn Healthcare SA, Switzerland.
© 2014 Eisai Inc. All rights reserved. Printed in USA. NEPA0013 10/14
The first fixed combination antiemetic that targets
both the NK
1
and 5-HT
3
pathways with 1oral dose.
For more information, visit AKYNZEO.com.
Indication
AKYNZEO is indicated for prevention of acute and delayed nausea and vomiting associated with initial and repeat
courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.
Important Safety Information
Warning and Precautions
•
Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to
other 5-HT
3
receptor antagonists
•
Serotonin syndrome has been reported with 5-HT
3
receptor antagonists alone but particularly with the use of
serotonergic drugs. Symptoms associated with serotonin syndrome may include the following combination of
signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, seizures, and
gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms
occur, discontinue AKYNZEO and initiate supportive treatment
Adverse Reactions
•
Most common adverse reactions (
≥
3% and greater than palonosetron): headache, asthenia, dyspepsia, fatigue,
constipation and erythema
Drug Interactions
•
Use with caution in patients receiving concomitant medications primarily metabolized by CYP3A4. The inhibitory
effect on CYP3A4 can last for multiple days
—Dexamethasone doses should be reduced when given with AKYNZEO
—Consider the potential effects of increased plasma concentrations of midazolam or other benzodiazepines
metabolized via CYP3A4 (alprazolam, triazolam) when administering with AKYNZEO
—Caution and monitoring for chemotherapy-related adverse events are advised in patients receiving chemotherapy
agents metabolized primarily by CYP3A4 including docetaxel, paclitaxel, etoposide, irinotecan, cyclophosphamide,
ifosfamide, imatinib, vinorelbine, vinblastine, and vincristine
•
Avoid concomitant use of AKYNZEO in patients on chronic use of a strong CYP3A4 inducer such as rifampin as this
may decrease the efficacy of AKYNZEO
Use in Specific Populations
•
Avoid use of AKYNZEO in patients with severe hepatic impairment, severe renal impairment, or end-stage renal disease
Please see brief summary of Full Prescribing Information on following pages.
NEW
